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EC number: 800-038-5 | CAS number: 1071838-81-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 february 2012 to 26 june 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed in accordance to OECD guideline 439
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- during the preliminary test for the detection of colouring potential of the test item, an additional colour evaluation after 1 hour of incubation was performed. It was considered not to have compromised the validity or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- copper(2+) bis(carbamimidoylurea) dinitrate
- EC Number:
- 800-038-5
- Cas Number:
- 1071838-81-7
- Molecular formula:
- Cu(C2H6N4O)2 (NO3)2
- IUPAC Name:
- copper(2+) bis(carbamimidoylurea) dinitrate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- other: human skin model
- Strain:
- other: EpiskinTM reconstituted human epidermis
- Details on test animals or test system and environmental conditions:
- TEST CELLS
- Source: SkinEthic Laboratories, Nice, FRANCE
- batch No. 12-EKIN-014
- Passage: second
- origin: adult donor
- quality control: histology scoring 21.7+/-0.3 (>or=19.5) and IC50 determination (SDS concetration, MTT test) 2.1 mg/ml (> or equal 1.5 mg/ml)
- expiration date: april 9, 2012
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37°C
- Humidity (%): saturated
- CO2: 5%
EXPERIMENT DATES: From: march 27, 2012 To: april 6, 2012
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- other: no preparation was needed because of in vitro test
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- original form
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied to each tissue: 10 mg +/- 2 mg - Duration of treatment / exposure:
- test item: 15 (+/-1) minutes
recovery time after treatment: 42 (+/- 1) hours - Observation period:
- no observation period. MTT viability assay was assessed after the end of the recovery period
- Number of animals:
- each condition was assessed in triplicate tissue
- Details on study design:
- NEGATIVE CONTROL
- Phosphate-Buffered saline 1X
- Lot/batch no. (if required): prepared by CiToxLAB, 020412A
-dose: 10 µl applied to negative control tissue
POSITIVE CONTROL
- sodium dodecyl sulphate (SDS) as a 5% (w/v) aqueous solution
- Lot/batch no. (if required): Bio-Rad, 111011A
-dose: 10 µl applied to positive control tissue
REMOVAL OF TEST SUBSTANCE
- at the end of incubation period (15 minutes)
- Washing (if done): test item was removed from the well of treatment plate and rinced with D-PBS.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 16
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 min exposure + 42h recovery. Reversibility: other: not relevant: in vitro test. (migrated information)
- Other effects / acceptance of results:
- irritant
no other effect
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- CuGUN is considered to be irritant to skin as the mean relative viability was <50% relative to the negative control. According to these results, the classification is irritant (R38), category 2 (H315)
- Executive summary:
The objective of this study was to evaluate the skin irritation potential of the test item,Copper Bis Guanylurea Nitrate (CuGUN),using the EpiskinTMreconstituted human epidermis model. The study design was based upon international guidelines (OECD Guideline No. 439 and Commission Regulation (EC) No. 640/2012, B.46) and the study was conducted in compliance with CIT’s standard operating procedures and the principles of Good Laboratory Practice.
Methods
Preliminary tests were performed to detect the ability of the test item to directly reduce MMT as well as its colouring potential.
Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 14 to 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 41 hours and 55 minutes at, 5% CO2in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay. Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability).
Results
Preliminary test
In the preliminary test, theMTT solution containing the test item was found blue when compared with the negative control. However according to the NSMTT% results of the CIT study No. 38756 TIC for the same test item, it was considered that the test item did not interact with MTT. The blue colouration of the MTT solution containing the test item was probably due to the intrinsic colour of the test item, consequently no additional controls were performed on water-killed tissues in parallel to the main test. The test item was found to have a colouring potential in the preliminary test as the water solution containing the test item was coloured. As a result, additional controls were used in parallel to the main test (two viable tissues were used: one was treated with the test item and the other with the negative control; these two tissues were not incubated with MTT)for the evaluation of the non specific OD.
Main test
The acceptance criteria for this test were:
. the mean cOD of the three negative controls (PBS) was≥0.6 and the standard deviation value of the % viability was≤18%,
. relative mean viability of the positive control (SDS) was ≤ 40% of the relative mean viability of the negative control and the standard deviation value of the % viability was ≤ 18%. All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid. Following a 15 minutes exposure and a 42-hour recovery period, the true relative mean viability of the tissues treated with the test item was 16%.
Conclusion
Under the experimental conditions of this study, the test item,Copper Bis Guanylurea Nitrate (CuGUN), is considered to be irritant to skin as the mean relative viability was<50%relative to the negative control (see the classification table below). According to these results, the classification of the test item is the following:
. irritant R38 (EU classification); Category 2 (H315) (Regulation EC No. 1272/2008 (CLP Regulation)).
Criteria forin vitroclassification
Interpretation
Directive 67/548/EEC
Regulation EC
No. 1272/2008
(CLP Regulation)Mean relative viability is ≤ 50%
Irritant
Irritant (R38)
Category 2 (H315)
Mean relative viability is > 50%
Non-irritant
Not classified
No category
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